NCT00579436

Brief Summary

The purpose of this study is to determine whether improvement in fat and muscle metabolism after the treatment with Omacor (fish oils) provides insight into the link between obesity, fat and muscle function leading to metabolic syndrome, which is a risk factor for heart disease and diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2013

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2015

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

May 16, 2018

Completed
Last Updated

May 16, 2018

Status Verified

April 1, 2018

Enrollment Period

6.2 years

First QC Date

December 20, 2007

Results QC Date

February 13, 2018

Last Update Submit

April 16, 2018

Conditions

Metabolic SyndromeInsulin Resistance

Keywords

inflammationobesitydiabetes

Outcome Measures

Primary Outcomes (2)

  • Baseline Adipocyte Size

    Prior to starting the fish oil regiment, participants will undergo an incisional abdominal biopsy to remove approximately 4g of adipose tissue to determine adipocyte size

    baseline

  • Adipocyte Size After Fish Oil Treatment

    After completing the fish oil regiment, participant will undergo an incisional abdominal biopsy to remove approximately 4g of adipose tissue to determine individual adipocyte size

    week 12

Secondary Outcomes (2)

  • Baseline Insulin Resistance

    baseline

  • Insulin Resistance After Fish Oil Regiment

    week 12

Study Arms (2)

Fish oil group

ACTIVE COMPARATOR

4g Lovaza (omega-3 fatty acid) daily.

Drug: omega-3 fatty acid

Control group

PLACEBO COMPARATOR

placebo (4 non-active capsules daily)

Drug: placebo

Interventions

omega-3 fatty acidDRUG

4g of omega-3 fatty acid daily by mouth for 12 weeks.

Also known as: Lovaza
Fish oil group
placeboDRUG

4 inert capsules daily by mouth for 12 weeks.

Control group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 27-45 kg/m2
  • age 35-65 years
  • abnormal carbohydrate metabolism

You may not qualify if:

  • triglycerides over 700 mg/dl
  • renal disease
  • liver disease
  • congestive heart failure
  • history of heart disease or stroke
  • chronic aspirin or NSAID use (anti-coagulant)
  • history of a bleeding disorder
  • use of statins, fibrates, ACE inhibitors, angiotensin II receptor blockers and glucocorticoids
  • diet heavy in omega-3 fatty acids (salmon, sardines, flaxseeds)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Medical Cener

Lexington, Kentucky, 40475, United States

Location

Related Publications (1)

  • Spencer M, Finlin BS, Unal R, Zhu B, Morris AJ, Shipp LR, Lee J, Walton RG, Adu A, Erfani R, Campbell M, McGehee RE Jr, Peterson CA, Kern PA. Omega-3 fatty acids reduce adipose tissue macrophages in human subjects with insulin resistance. Diabetes. 2013 May;62(5):1709-17. doi: 10.2337/db12-1042. Epub 2013 Jan 17.

    PMID: 23328126RESULT

MeSH Terms

Conditions

Metabolic SyndromeInsulin ResistanceInflammationObesityDiabetes Mellitus

Interventions

Fatty Acids, Omega-3Omacor

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Limitations and Caveats

Study not being powered to identify a difference between groups

Results Point of Contact

Title
Phillip Kern
Organization
University of Kentucky
pake2222@uky.edu
859 323 4933

Study Officials

  • Philip A. Kern, M.D.

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 24, 2007

Study Start

January 1, 2007

Primary Completion

March 27, 2013

Study Completion

January 15, 2015

Last Updated

May 16, 2018

Results First Posted

May 16, 2018

Record last verified: 2018-04

Locations

US(1)